That’s all about to change, if Stefano Di Lullo has anything to say about it.

Di Lullo, president of Sorin Group, is helping to spearhead the company’s push into the U.S. CRM market. Earlier this month he announced the launch here of a complete line of pacemakers and defibrillators, sending a clear signal that Sorin intends to make a run for it in America.

But it’s the company’s SonR technology that has Di Lullo really excited. SonR uses hemodynamic measurements and a software algorithm to fine-tune cardiac rhythm therapy for each patient’s particular condition.

"I really personally believe that it’s probably one of the major innovations in this space today," Di Lullo told MassDevice.com when we caught up with him at the recent Heart Rhythm Society meeting in Boston.

Di Lullo gave us the background on Sorin’s push into the U.S. CRM space and the lowdown on why he believes the SonR technology is a true game-changer.

MassDevice.com: Sorin has a large presence in Europe, but is less well-known here in the U.S. Can you give us a primer on the company and its plans for the U.S. market?

Stefano Di Lullo: Sorin does about €800 million in terms of sales, worldwide. We have 3 business units, 1 of which is cardio-pulmonary – within that’s heart-lung machines, CRM, etc. We’re world leaders in that area, so we’ve got upwards of 35% market share worldwide.

On the heart-lung machine side, we’re over 60-65% market share, and I’d say that’s consistent worldwide: Leaders in the U.S., leaders in Europe and emerging markets.

Then, in heart valves, we’re number 2 in the world and in the U.S. Our growth is coming primarily from tissue valves. Four years ago we launched the Mitroflow aortic tissue valve in the U.S. and that’s been our growth driver. On the tissue valve market, we’re probably worldwide in the 20% range, in the U.S… I’m trying to think of the last quarter, but say we’re in the 11-12% range market share in the U.S.

And then our 3rd business unit is CRM – I’d say a little over a third of the company – and our presence in CRM is primarily European and OUS, so we’re probably no. 2 or no. 3 in Europe, we’re no. 2 in Japan, we’ve got countries like France where we’re no. 1, and in the U.S. we have a very small presence.

A big reason for that has been the fact that, contrary to other areas of the world, we have not had a full offering in the U.S. That’s why we’re so excited about the announcements that we made this week. We’ve got now, for the U.S. market, a full range of bradytachy and [left ventricular] leads, we’ve just announced the approval of our remote monitor-enabled high-voltage devices and we’re hoping our remote system will be approved during Q4 this year.

So really, for the first time, we will have a full offering. Obviously, we’re very bullish about what that means for us in the U.S. market.

MassDevice.com: What else does Sorin have in the pipeline for the U.S.?

SDL: The other big thing is that we’re talking to the FDA about approving an [investigational device exemption] for our SonR technology, which has been approved in Europe. It’s the only technology today that has demonstrated the ability to improve response rate to [cardiac rhythm therapy] in a peer-reviewed study. Our Clear study has just been published in EuroPace.

Essentially there’s 2 parts to the SonR system. We have a sensor on the tip of a brady lead that basically measures hemodynamic movement of the heart. It measures vibration of the heart, translates that into an electronic signal and sends it back to the device. Then there’s an algorithm in the device that interprets that signal into a hemodynamic measurement of how the heart is actually working.

It measures the vibration in the left ventricle, but while we’re placing it in the right side of the heart. We can measure the vibrations in the left ventricle; we take a series of measurements and by that we get an interpretation of the hemodynamic function of the left ventricle.

Using those measures we then determine the appropriate [anti-bradycardia] lead delay and optimize the patient. The big difference between what’s been done previously, and has not been successful in clinical studies, is that it’s always been an electrical measurement of what the heart is doing and trying to correlate that into an optimization algorithm. We actually measure hemodynamic performance of the heart. The 2nd big difference is that we optimize weekly, and both at rest and at exercise.

By definition, heart failure is a dynamic disease. So you’ll implant the patient with the CRT, and assuming they respond, the heart will start reverse-remodeling the ventricle. The heart gets better, so as it reverse-remodels you change the hemodynamic nature of how the heart is functioning, which normally you should then change the delay.

MassDevice.com: It sounds as though the device adapts to changing conditions as the heart muscle remodels.

SDL: It does, it’s an adaptive device. In some cases, the patient will get worse after CRT, because again the disease progresses. So after a year, the patient might get worse, they might not follow the drug regimen as well, etc. As the heart starts remodeling again, the SonR device will adapt to that.

We believe the reason our studies showed a positive outcome is because we’ve got a device that will adjust its therapy on an individualized basis for each patient, and will do it weekly. It’s a truly adaptive system, which we think is the key – 1 of the keys. The 2nd key is that we’re doing it based on hemodynamic measures, which we think are more representative of what’s going on than an electrical measure.

We’ve launched SonR in Europe, so far to really good success. We’ve got more than 200 customers on it, with about a 65% re-order rate, so we’re really happy with how it’s gone so far.

Having said that, getting approval in the U.S. is going to go through an IDE, so we’ve started another study where we’re going to be enrolling 600-700 patients. It’s called Respond. We’re having discussions with the FDA right now around the study. We’ve already started enrollment in Europe, and obviously we’re looking forward to getting approval of the IDE and getting some U.S. experience with this technology.

It’ll be 600-700 patients worldwide, randomized at 2/3 in the treatment arm, 1/3 in the control arm, and double-blinded. The control is daily practice, so what they currently do; so if they do [echocardiography], it’s with echo; if they don’t do echo, it’s just daily practice.

We really believe it’s truly 1 of the major innovations in the marketplace today, both from a patient outcome point of view, in terms of what it means for the patient, and more importantly in terms of improved efficacy.

Di Lullo

Healthcare systems, at least in the developed world, are looking at how to become more effective, more efficacious. When you think that, today, 1 CRT-D out of 3 you might as well just throw away because your patient is not responding – in our Clear study we’ve taken that and improved it to about a 76% response rate.

So if we can now say, instead of 2 out of 3 that work, it’s 3 out of 4 that work, that’s a huge benefit in terms of the effectiveness for health care systems. There’s obviously the patient benefit story, which is great, but there’s a health economics story that goes along with that which we think the timing of is just perfect.

Albeit I’m not objective, but I really personally believe that it’s probably 1 of the major innovations in this space today.

Innovation is really our lifeblood. We’ve got a history of that. I think SonR is that and we’re continuing to invest in other areas related to optimizing the delivery of heart failure treatment, whether it be through neuromodulation approaches, new approaches to improve lead technology, etc. But SonR is going to be the core of all of that.

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